Real-world adverse event profiles of Zuranolone and Brexanolone based on FAERS and VigiAccess databases: An observational study.

چکیده اصلی

Zuranolone and Brexanolone are Food and Drug Administration-approved novel agents for postpartum depression, yet real-world post-marketing safety data for the two drugs remain insufficient. This study aimed to systematically characterize their adverse event (AE) profiles via two authoritative pharmacovigilance databases, namely the Food and Drug Administration Adverse Event Reporting System (FAERS) and VigiAccess. FAERS data from Q1 2019 to Q3 2025 and VigiAccess data updated to November 2025 were extracted. Reporting odds ratio and proportional reporting ratio were adopted to screen and compare AE signals of the two drugs. A total of 631 primary suspect (PS) drug reports for Zuranolone and 102 for Brexanolone were extracted from FAERS, whereas 863 Zuranolone and 227 Brexanolone reports were obtained from VigiAccess. At the system organ class level, AEs associated with Zuranolone involved 22 SOCs in FAERS and 24 SOCs in VigiAccess, with the top three SOCs sorted by reported cases as follows: Nervous system disorders, Psychiatric disorders, and General disorders and administration site conditions (FAERS); Nervous system disorders, General disorders and administration site conditions, and Psychiatric disorders (VigiAccess). For Brexanolone, AEs retrieved from FAERS involved 16 SOCs, compared with 21 SOCs in VigiAccess; the top three SOCs by the number of reported cases were Injury, poisoning and procedural complications, General disorders and administration site conditions, and Psychiatric disorders. After signal screening in the FAERS database, a total of 78 positive signals (involving 9 SOCs) were identified for Zuranolone, whereas 10 positive signals (involving 4 SOCs) were detected for Brexanolone. Four SOCs were commonly implicated in the positive AE signals of both drugs, with the most commonly reported AEs including gait disturbance, exposure via breast milk, fatigue, and therapy cessation. Additionally, compared to Brexanolone, 5 SOCs were uniquely associated with Zuranolone, with the most commonly reported AEs such as vertigo, vision blurred, muscle twitching, somnolence, and loss of personal independence in daily activities. Zuranolone's AEs mainly involved nervous system disorders and Psychiatric disorders, while Brexanolone's primarily included Injury, poisoning and procedural complications, and Psychiatric disorders. This study would provide more safety reference data for the clinical use of two drugs.

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